safety study to evaluate daptomycin in non-infected adults who are either on hemodialysis or continuous ambulatory peritoneal dialysis (mk-3009-021)

Conditions: End-Stage Renal Disease

Summary: this study is to examine the safety of daptomycin in patients with end stage renal disease.

this is an open label, non-randomized, non-comparative phase 1 study designed to evaluate the pk profile, safety and tolerability of intravenous ( i.v.) daptomycin. non-infected subjects with end stage renal disease undergoing hemodialysis (hd) or continuous ambulatory peritoneal dialysis (capd) will be enrolled in this in-patient study.

Eligibility criteria:
inclusion criteria: * written informed consent prior to any study-related procedure not part of normal medical care; * considered to be in appropriate health for study entry by the investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment; * male or female \>18 years of age; * if female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating/pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for \>28 days after study completion; * if taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study medication administration; * functioning dialysis access (e.g. graft or fistula) for subjects undergoing hd and functioning dialysis access (e.g. peritoneal catheter) for subjects undergoing capd; * esrd on stable hd regimen of thrice weekly sessions with high-flux membranes or stable capd regimen. exclusion criteria: * if female, pregnant or lactating; * received an investigational drug (including experimental biologic agents) within 30 days of study entry; * evidence of active ongoing infection; * unable to discontinue use of hmg-coa reductase inhibitor therapy for duration of study; * has received any dose(s) of daptomycin within 5 days prior to receiving the first dose of study drug; * known to be allergic or intolerant to daptomycin; * body mass index (bmi) \ 40 kg/m2 \[bmi = weight (kg)/height (m2)\]; * wbc \>12, 000 cells/mm3 or \<2500 cells/ mm3; * baseline creatinine phosphokinase (cpk) values \>3x uln (upper limit of normal); * alanine aminotransferase (alt) \>5x uln; * aspartate aminotransferase (ast) \>5x uln; * known hiv-infected subjects with cd4 count ≤200 cells/mm3; * hemoglobin \< 9 gm/dl; * active illicit drug and/or alcohol abuse; * myocardial infarction within last 6 months; * hospitalized for non-vascular or peritoneal dialysis (pd) access issues within 30 days; * subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy); * subjects with a history of neurological disease (e.g., guillain barré, multiple sclerosis), except stroke \>6 months prior to study entry; * intramuscular injection within 7 days of study drug administration; * has a moribund clinical condition (i.e., high likelihood of death during the next 3 days); * is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations; * neutropenic subjects with absolute neutrophil count ≤500 cells/mm3 history of rhabdomyolysis.

Keywords: esrd dialysis hemodialysis continuous ambulatory peritoneal dialysis